As we all know that symbols play a very important part in medical device labeling, hence it is critical to know when the relevant standard undergoes changes. If you are a medical device manufacturer or Innovator and want to know more about the latest version of the ISO 15223-1:2021, then, this article is for you!…
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Medical devices – Quality management systems – Requirements for regulatory purposes The release of the 2021 Amendment of ISO 13485:2016 has created a lot of curiosity amongst medical device organizations and quality professionals. The question which most of us have is: “What is new in the 2021 amendment of ISO 13485 standard?” Do not worry!…
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Medical devices – What information is to be supplied by the manufacturer? As we are very much aware that the ISO 20417:2021 standard is already in town, Elexes Team has detailed in this article the need for the new labeling standard, ISO 20417:2021, which entails the information to be supplied by the manufacturers for a medical device…
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Introduction to Quality Management System Quality is the most important criterion to be fulfilled by medical device manufacturers to satisfy customers. Medical devices have an impact on the health of the patients, and thus various regulatory bodies across the world also mandate the implementation of the Quality Management System (QMS) for which the most widely…
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The purpose of conducting an Internal Audit is to evaluate the efficiency of an organization in terms of quality processes, risk management, and overall business practices with respect to applicable standards and regulations. An internal audit is a means of identifying any shortcomings in the quality processes in order to plan actions to correct and…
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Biological evaluation of medical devices – Part 12: Sample preparation and reference materials We all are aware that the 2021 version of the ISO 10993-12 has been released and there is anxiety amongst the medical device professionals and manufacturers regarding the new additions in the amendment. Since this standard has repealed the 2012 version of…
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Can you imagine using life-saving medical devices that have not been certified for quality, safety and efficacy? These aspects if compromised, can result in enormous adverse effects and are simply non-negotiable! Let’s take a look at how one can prove their devices to be safe and effective and ensure high quality throughout its life. ISO…
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What is continuous improvement and how can we achieve it? An answer to this is a premeditated and well-implemented quality management system (QMS). A QMS, in simple words, is a system in which documents on various processes, relevant to the medical device or activities around it, are maintained. This does not mean that QMS is…
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Has managing documents always been a tedious and time consuming task for you? Have you faced issues of cost drain and compliance while maintaining the documents for medical devices? We understand! read below to learn about some document control systems that can help make almost any business more efficient. Due to the very nature of…
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The software has become an integral part of almost all facets of life. It has pronounced usage in the healthcare and medical field. There are three types of software related to medical devices. SaMD is software which on its own is a device employed for a medical purpose. The International Medical Device Regulators Forum (IMDRF)…
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Background
Mr. Amit is a Biomedical Engineer with a strong background in medical device technology. With over 10 years of overall experience where 6 years were spent by Amit in core medical device troubleshooting and compliance, Amit is able to adopt a very pragmatic approach when helping Clients with testing and compliance issues. Amit is a dedicated professional with attention to details. He has helped successfully navigate many Clients through various stages of regulatory approvals.
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Background
An executive with 15+ years of global, medical and research experience. Demonstrated successes through NIH grant acquisition, board certification, launch campaigns, and executive leadership. Proven industry experience across multiple therapeutic areas (Oncology, Psychiatry, Neurology, etc): Medical Affairs (MA) operations – Medical Education & Writing – Clinical research (P1-4) – Regulatory Affairs – Strategy – leadership –organizational development. Medical Affairs management experience has continually been enhanced from developing new departments to assisting well-established ones for companies with annual revenues of $10M to multi-billion. A natural leader that leverages innate and trained communication skills to effectively coach staff, build talent, develop robust teams, minimize conflict, and drive projects to successful completion with a sense of purpose and attention to detail.
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Background
Mr. Vivek Goyal is an IIT Electrical Engineering and Stanford GSB alumni. He is highly passionate about creating successful businesses, helping companies optimally position themselves and their value proposition, and solving various complex technological problems through advanced software methodologies.
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Background
Ms. Parul is a Biomedical Engineer by profession with more than 15 years of medical device and IVD experience. Parul is a Certified Quality Auditor (CQA) by American Society for Quality (ASQ), RAC certified by RAPS, a trusted thought leader and a decision maker for regulatory strategy, product testing, design controls, risk management, supplier control, quality assurance, regulatory compliance, clinical evaluations, and post-market controls. With a Masters in Bioengineering from UIC, Chicago, she is passionate for medical device and IVD development and has served as the Regulatory and Quality Director for several medical device companies across the world.
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